37286 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

PART 180–[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority : 21 U.S.C. 346a and 371.

2. In § 180.442, by amending the table

under paragraph (b) by revising the

entry for ‘‘Raspberries’’ to read as

follows:

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

Revocation

Date

* * * * * * *

Raspberries ....... 3.0 12/31/99

* * * * * * *

* * * * *

[FR Doc. 98–18279 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300665; FRL–5794–3]

RIN 2070–AB78

Gliocladium Catenulatum Strain J1446;

Exemption from the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of the biological

pesticide Gliocladium catenulatum

strain J1446 in or on all agricultural

commodities. Kemira Agro Oy

submitted a petition to EPA under the

Federal Food, Drug and Cosmetic Act as

amended by the Food Quality Protection

Act of 1996 requesting the tolerance

exemption. This regulation eliminates

the need to establish a maximum

permissible level for residues of

Gliocladium catenulatum strain J1446.

DATES: This regulation is effective July

10, 1998. Objections and requests for

hearings must be received by EPA on or

before September 8, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300665],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (‘‘Tolerance Petition Fees’’

and forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing requests filed

with the Hearing Clerk identified by the

docket control number, [OPP–300665],

must also be submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of electronic objections and hearing

requests must be identified by the

docket number [OPP–300665]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Susanne Cerrelli, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460,

Office location and telephone number,

and e-mail address: CM #2 Rm. 902

W48, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–8077, e-mail

address:

cerrelli.susanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 25, 1997 (62 FR

34271)(FRL–5721–7), EPA issued a

notice pursuant to section 408(d), of the

Federal Food, Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(d), announcing

the filing of a pesticide tolerance

petition by Kemira Agro Oy (PP

7F4137). The notice contained a

summary of the petition prepared by the

petitioner and this summary contained

conclusions and arguments to support

its conclusion that the petition

complied with the Food Quality

Protection Act (FQPA) of 1996. The

petition requested that 40 CFR part 180

be amended by establishing an

exemption from the requirement of a

tolerance for residues of the biological

pest control agent Gliocladium

catenulatum strain J1446. There were

no comments received in response to

the notice of filing.

The data submitted in the petition

and other material have been evaluated.

The toxicology data requirements in

support of this exemption from the

requirement of a tolerance were satisfied

via submitted data.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue and to ‘‘ensure that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to the pesticide

chemical residue...’’ Additionally,

section 408(b)(2)(D)(v) requires that the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

II. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37287

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

All available information indicates

that Gliocladium catenulatum strain

J1446 is of low toxicity. Acute oral

toxicity/pathogenicity, dermal irritation

and eye irritation were classified

toxicity category IV. Acute oral toxicity/

pathogenicity limit test and acute

pulmonary toxicity/pathogenicity tests

were classified category III. Gliocladium

catenulatum strain J1446 did not

survive, replicate, infect, or produce

disease in test animals injected with a

single high dose of this microbial agent.

No mechanism of toxicity was identified

for Gliocladium catenulatum, therefore

a common mechanism of human

toxicity with other agents is not

indicated, so no cumulative effects are

considered.

III. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures, including

drinking water from groundwater or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

1. Dietary exposure. (a) Food. The use

of Gliocladium catenulatum strain J1446

is not expected to result in any new

dietary exposure to this organism. Fungi

such as Gliocladium catenulatum strain

J1446 are ubiquitous in the agricultural

environment. It is anticipated that the

concentrations of Gliocladium

catenulatum on treated plants may be

elevated immediately after application

but will rapidly decline to

environmental background levels. The

risks anticipated for dietary exposure

are considered minimal because no

signs of toxicity were observed in the

acute oral toxicity/pathogenicity studies

(Toxicity Category IV).

(b) Drinking water. Gliocladium

catenulatum strain J1446 is a naturallyoccurring fungus and is widespread in

the environment throughout the world.

Gliocladium catenulatum is not known

as an aquatic fungus, and therefore is

not expected to proliferate in aquatic

habitats. Moreover, Gliocladium

catenulatum is not considered to be a

risk to drinking water. Drinking water is

accordingly not being screened for

Gliocladium catenulatum as a potential

indicator of microbial contamination or

as a direct pathogenic contaminant.

Both percolation through soil and

municipal treatment of drinking water

would reduce the possibility of

exposure to Gliocladium catenulatum

through drinking water. Therefore, the

potential of significant transfer to

drinking water is minimal to nonexistent.

2. Other non-occupational exposure.

Other non-occupational exposure of

Gliocladium catenulatum strain J1446

via residential and indoor uses of it as

a pesticide, e.g., uses around homes,

parks, recreation areas, will be minimal

to non-existent. The risk from nonoccupational exposure is considered

minimal as there is no evidence of

adverse effects from oral, dermal or

inhalation exposure to this microbial

agent.

(a) Dermal exposure. The risks

anticipated for this route of exposure are

considered minimal because no signs of

dermal toxicity or irritation were

observed in the acute dermal toxicity

and irritation studies (Toxicity Category

IV).

(b) Inhalation exposure. The risks

anticipated for this route of exposure are

considered minimal because this

microbial agent did not exhibit toxicity

and pathogenicity in the acute

pulmonary toxicity/pathogenicity

studies. (Toxicity Category III) The

anticipated risks from aggregate

exposure via dermal and inhalation are

a compilation of two low risk exposure

scenarios and are considered negligible.

IV. Other Considerations

1. Endocrine disrupters. The Agency

has no information to suggest that

Gliocladium catenulatum has an effect

on the immune and endocrine systems.

No specific tests have been conducted

with Gliocladium catenulatum strain

J1446 to determine such effects.

However, as is expected from a nonpathogenic microorganism, the

submitted toxicity/pathogenicity studies

in rodents indicated that following

several routes of exposure, the immune

system is still intact and able to process

and clear the active ingredient. There

are no reports indicating that

Gliocladium catenulatum strain J1446

produces any toxins or antibiotics.

Therefore, it is unlikely that this

organism would have estrogenic or

endocrine effects because it has

demonstrated low mammalian toxicity.

The Agency is not requiring information

on the endocrine effects of this

biological pesticide at this time;

Congress has allowed 3 years after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

2. Analytical method. The Agency

proposes to establish an exemption from

the requirement of a tolerance without

any numerical limitation; therefore, the

Agency has concluded that an analytical

method is not required for enforcement

purposes for Gliocladium catenulatum.

3. Codex Maximum Residue Level.

There are no CODEX tolerances nor

international tolerance exemptions

established for Gliocladium

catenulatum strain J1446 at this time.

V. Determination of Safety for U.S.

Population, Infants and Children

Based on all available information,

the Agency concludes that Gliocladium

catenulatum strain J1446 has no

significant toxicity. Further, there is no

evidence which suggests that aggregate

exposure of either adults or infants and

children to Gliocladium catenulatum

leads to any harm. Accordingly, EPA

concludes that there is a reasonable

certainty that no harm will result to the

U.S. population or any significant

subpopulation, including infants and

children, from aggregate exposure under

this exemption.

FFDCA section 408 provides that EPA

shall apply an additional ten-fold

margin of exposure (safety) for infants

and children in the case of threshold

effects to account for pre- and post-natal

toxicity and the completeness of the

database, unless EPA determines that a

different margin of exposure will be safe

for infants and children. Margins of

exposure are often referred to as

uncertainty (safety) factors. In this

instance, the Agency believes there is

reliable data to support the conclusion

that this microbial agent is practically

non-toxic to mammals, including

infants and children, and, thus, there

are no threshold effects; therefore, EPA

has not used a margin of exposure

approach to assess the safety of

Gliocladium catenulatum strain J1446.

As a result, the provision requiring an

additional margin of exposure does not

apply.

VI. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a regulation

for an exemption from the requirement

of a tolerance issued by EPA under new

section 408(d) as was provided in the

old section 408 and in section 409.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which govern the submission of

objections and hearing requests. These
37288 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

regulations will require some

modification to reflect the new law.

However, until those modifications can

be made, EPA will continue to use those

procedural regulations with appropriate

adjustments to reflect the new law.

Any person may, by September 8,

1998, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the hearing clerk, at the

address given under the ‘‘ADDRESSES’’

section (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the hearing clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VII. Public Docket and Electronic

Submissions

A record has been established for this

rulemaking under docket control

number [OPP–300665]. A public version

of this record, which does not include

any information claimed as CBI, is

available for inspection from 8:30 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 119 of the

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA 22202.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing request,

EPA will transfer any copies of

objections and hearing requests received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record. The official rulemaking record is

the paper record maintained at the

Virginia address in ADDRESSES at the

beginning of this document.

VIII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). Nor does it require and

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In additions, since tolerance

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business.

IX. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and the Comptroller General of

the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 24, 1998.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371

2. Section 180.1198 is added to read

as follows:

§ 180.1198 Gliocladium catenulatum strain

J1446; exemption from the requirement of

a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of the microbial pesticide, Gliocladium
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37289

catenulatum strain J1446 when used in

or on all food commodities.

[FR Doc. 98–18277 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300678; FRL–5798–6]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of myclobutanil in or on

caneberries, and in or on dried hop

cones. This action is in response to

EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on caneberries in Oregon, and

use of the pesticide on hops in Idaho,

Oregon, and Washington. This

regulation establishes a maximum

permissible level for residues of

myclobutanil in these food commodities

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerances

will expire and be revoked on December

31, 1999.

DATES: This regulation is effective July

10, 1998. Objections and requests for

hearings must be received by EPA on or

before September 8, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300678],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300678], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300678]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: David Deegan, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9358, e-mail:

deegan.dave@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for combined residues of the

fungicide myclobutanil ù-butyl-ù-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile plus its alcohol

metabolite ù-(3-hydroxybutyl)-ù-(4-

chlorophenyl)-1H-1,2,4-triazole-1-

propanenitrile (free and bound), in or on

caneberries at 1.0 part per million

(ppm), and in or on dried hop cones at

5.0 ppm. These tolerances will expire

and be revoked on December 31, 1999.

EPA will publish a document in the

Federal Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.